Cleared Traditional

K990585 - INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER

K990585 is an FDA 510(k) clearance for INTERACOUSTICS AT22T AUTOMATIC IMPEDANC..., manufactured by Idem (Int'L Dist. of Electronics For Medicine). The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K990585 · Idem (Int'L Dist. of Electronics For Medicine) · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
83d
Days
Class 2
Risk

K990585 is an FDA 510(k) clearance for the INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Idem (Int'L Dist. of Electronics For Medicine) (Benicia, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Idem (Int'L Dist. of Electronics For Medicine) devices

FDA 510(k) Submission Details - K990585

510(k) Number K990585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date May 17, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 90d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETY Tester, Auditory Impedance

All 45
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K990585.
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K994254 · International Distributors of Electronics For Medi · Mar 2000
PASCAL MEDICAL AB MENIETT 20
K991562 · Pascal Medical AB · Dec 1999
AMPLAID A724 AND A728
K992370 · Amplifon S.P.A. · Sep 1999
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
K990652 · Idem (Int'L Dist. of Electronics For Medicine) · May 1999
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
K983832 · Idem (Int'L Dist. of Electronics For Medicine) · Jan 1999
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
K983049 · American Electromedics Corp. · Nov 1998